An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits

NCT06287385 | Completed

• 1 other identifier: NELN202212A
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives.

Conditions

Healthy Children

Outcome Measures

Primary Outcomes (1)

• Stool characteristics

  Stool characteristics assessed with BITSS

  before and 7, 14, 21 and 28 days after administration of the investigational product

Secondary Outcomes (3)

• Gastrointestinal symptoms

  before and 7, 14, 21 and 28 days after administration of the investigational product

• Quality of life of subjects

  before and 28 days after administration of the investigational product

• Lifestyle-related immune indicators

  before and 28 days after administration of the investigational product

Other Outcomes (1)

• Safety assessment includes adverse events as reported spontaneously by parents or collected by investigators.

  screening until 4 weeks after product intervention

Study Arms (1)

Formula fed

EXPERIMENTAL

Goat-milk Based Formula (Stage 3)

Dietary Supplement: Goat-milk Based Formula

Interventions

Goat-milk Based Formula DIETARY_SUPPLEMENT

Provided Goat-milk Based Formula for babies 1-2 years old

Formula fed

Eligibility Criteria

• Age: 1 Year - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 1-2 years of age
• Healthy term infants, gestational ages 37\~42 weeks
• Birth weight within normal range for gestational age and sex (10th to 90th percentile of the Chinese Child Growth Chart);
• Normal weight, height at screening (10th to 90th percentile of the Chinese Child Growth Chart)
• Chinese population;
• Subjects whose parents/guardians are intending to goat formula feed according to protocol during the study period;
• Informed consent from one parent or legal representative;
• Subjects whose parents/guardians are adults, have sufficient ability in Chinese to complete informed consent and other study documents;
• Subjects whose parents/guardians are able to use smart phone with cameras; install and use a secure WeChat platform on the mobile phone during the study period; connect to the network through the mobile phone; take photos to record stool; complete questionnaires;
• Subjects whose parents/guardians can be directly contacted by telephone or WeChat throughout the study.

You may not qualify if:

• Probiotics or probiotics-supplemented products use within 4 weeks prior to enrolment;
• Goat-milk based formula or fresh goat milk use within 4 weeks prior to enrolment;
• Special infant formula use within 4 weeks prior to enrolment, including but not limited to hydrolysed infant formula, lactose-free infant formula and anti-reflux infant formula etc.;
• Known allergy to milk products or soy product;
• Medially diagnosed disorders requiring a special diet, including but not limited to reflux esophagitis, phenylketonuria etc;
• Significant congenital abnormality or other health conditions that could affect the outcome measurements;
• Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
• Participation in any other studies involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study.

Sponsors & Collaborators

• Danone Nutricia: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Study Officials

• Zailing Li, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: March 28, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 5, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)